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临床试验/NCT03438019
NCT03438019Unknown不适用

Inspiratory Muscle Strength and Endurance Training in Veterans With COPD

Miami VA Healthcare System2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年6月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
36
试验地点
2
主要终点
Sustained Maximal Inspiratory Pressure (SMIP)

研究概览

简要总结

This proposal aims at evaluating an inspiratory muscle training (IMT) method not previously tested in COPD called the Test of Incremental Respiratory Endurance (TIRE). As a training method, TIRE promises to provide further benefits over standard IMT because it allows the user to adjust training loads as progress is made, adjusts the training based on day-to-day variations commonly noted in COPD, and provides a graphic representation of the inspiratory effort throughout all inspiration with real-time biofeedback in order to "coach" the user in performing the exercises. The TIRE device can also be used as an assessment tool, not only to measure the commonly used measure of inspiratory muscle strength Maximal Inspiratory Pressure (MIP), but also measuring the MIP variation generated throughout a maximal sustained inspiration. In this way, TIRE integrates MIP over the inspiratory duration (ID), providing a novel derivative measure called the sustained maximal inspiratory pressure or SMIP, that is likely a better surrogate of inspiratory muscle performance in COPD based upon preliminary data. The main goal of this trial is to fully evaluate the utility of TIRE as an IMT method in veterans with COPD. The investigators hypothesize that as a stand-alone therapy, TIRE training is superior to standard IMT in improving inspiratory muscle strength and endurance and in improving COPD-related clinical outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female aged > 40 years with a confirmed diagnosis of COPD by a pulmonologist (presence of risk factors and airflow obstruction) and evidence of inspiratory muscle weakness as defined by the latest American Thoracic Society / European Respiratory Society statement on respiratory muscle training.

排除标准

  • Refusal to participate in the study, subjects actively undergoing pulmonary rehabilitation, inability to perform the required maneuvers (i.e. patients with cerebrovascular accident or tracheostomy), subjects not in their stable state (i.e. having an acute exacerbation or within 4 weeks of having one) or presence of important comorbidities that may confound the interpretation of TIRE measures (i.e. decompensated heart failure, diaphragmatic paralysis, prior lung surgery, active cancer treatment, etc.). There will be no involvement of vulnerable populations.

研究组 & 干预措施

TIRE IMT

Experimental

The TIRE IMT group will receive a tablet with the TIRE software installed and a PrO2® device through which they will train. Training consists of six levels (A-F) with six inspirations at each level for a total of 36 breaths. Recovery times between breaths range from 40 to 5 seconds as the subject advances each level. TIRE data will be stored in the tablet for subsequent interrogation and data retrieval.

干预措施: PrO2 (Device)

Standard IMT group

Experimental

The Standard IMT group will receive a Threshold® Inspiratory Muscle Trainer. This device incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting to be set based on MIP values of each subject. Subjects will be instructed to perform up to 36 breaths daily. To compare with TIRE training, we will ask participants to perform this within a 30-minute session.

干预措施: Threshold Inspiratory Muscle Trainer (Device)

Sham IMT group

Sham Comparator

The Sham IMT group will also receive a Threshold® device and undergo the exact protocol of group 2 but with minimal resistance applied (7 cm H2O, the lowest in the device).

干预措施: Threshold Inspiratory Muscle Trainer (Device)

结局指标

主要结局

Sustained Maximal Inspiratory Pressure (SMIP)

时间窗: Change from baseline to 8 weeks.

SMIP is obtained from a maximal sustained inspiratory effort performed through the TIRE method using the PrO2 device. SMIP is documented in pressure time units (PTU) and represents the area under the curve generated from the start to the end of inspiration, from residual volume to total lung capacity.

次要结局

  • Maximal Inspiratory Pressure (MIP)(Change from baseline to 8 weeks.)
  • Inspiratory Duration (ID)(Change from baseline to 8 weeks.)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Michael Campos

Principal Investigator

Miami VA Healthcare System

研究点 (2)

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